Oropharyngeal candidiasis

Systemic candidiasis

Tinea manuum, Tinea pedis

Cryptococcal meningitis

Onychomycosis

Pityriasis versicolor

Non-meningeal cryptococcosis

Vulvovaginal candidiasis

Histoplasmosis

Aspergillosis

Tinea corporis, Tinea cruris

Primary prophylaxis of infection in AIDS patients, Primary prophylaxis of infection in neutropenic patients, Secondary prophylaxis of infection in AIDS patients, Secondary prophylaxis of infection in neutropenic patients

Blastomycosis

Absorption of itraconazole capsules may be decreased by certain antacids such as  Al hydroxide, H2-receptor antagonists, PPIs.

Plasma concentrations may be decreased by rifampicin, rifabutin, isoniazid, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz.

Plasma concentrations may be increased by ciprofloxacin, clarithromycin, erythromycin, indinavir, ritonavir.

May increase the plasma concentrations of tamsulosin, certain opioid analgesics (e.g. alfentanil, sufentanil, buprenorphine, fentanyl, oxycodone), digoxin, certain anticoagulants (e.g. rivaroxaban, cilostazol, coumarins, dabigatran), repaglinide, saxagliptin, praziquantel, certain antihistamines (e.g. bilastine, ebastine), certain antineoplastics (e.g. docetaxel, vinca alkaloids, , imatinib), certain antipsychotics, anxiolytics and hypnotics (e.g. risperidone, alprazolam, buspirone, quetiapine, aripiprazole, haloperidol, midazolam IV), verapamil,  aliskiren, bosentan, , aprepitant, certain corticosteroids (e.g. budesonide, fluticasone, methylprednisolone, ciclesonide), salmeterol, certain immunosuppressants (e.g. ciclosporin, tacrolimus), certain urological drugs (e.g. tadalafil, sildenafil, darifenacin), tolvaptan, artemether and lumefantrine, atorvastatin.

Increased risk of QT prolongation and ventricular tachyarrhythmia (including torsades de pointes) with disopyramide, quinidine, methadone, levacetylmethadol, astemizole, mizolastine, terfenadine, halofantrine, cisapride, domperidone.

Side effects may include any of the following: headache, dizziness, stomach pain, nausea, vomiting, diarrhoea, constipation, indigestion, chest pain, chills, fever, tiredness, confusion, joint or muscle pain

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• signs and symptoms of severe allergic reactions e.g. rashes, breathlessness, swelling of the face, eyes or mouth
• signs and symptoms of heart failure e.g. shortness of breath, swelling of your feet, ankles or legs, sudden weight gain, unusual tiredness, fast heartbeat, waking up with shortness of breath at night
• signs and symptoms of liver impairment e.g. yellowing of the skin or eyes, abdominal pain, dark coloured urine, tiredness, swelling in the legs and ankles
• tingling sensation, weakness or numbness in the hands or feet
• sudden temporary or permanent hearing loss

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Warnings and precautions

• Cases of CHF, peripheral edema, and pulmonary edema have been reported with itraconazole administration among patients being treated for onychomycosis and/or systemic fungal infections. 
• Cardiac Dysrhythmias Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), methadone, or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors. Concomitant administration of these drugs with itraconazole is contraindicated.
• Itraconazole should not be administered in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. Itraconazole has been shown to have a negative inotropic effect.  For patients with risk factors for congestive heart failure, physicians should carefully review the risks and benefits of itraconazole therapy. 
• In patients with elevated or abnormal liver enzymes or active liver disease, or who have experienced liver toxicity with other drugs, treatment with itraconazole is not recommended. Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. If clinical signs or symptoms develop that are consistent with hepatotoxicity, treatment should be discontinued immediately and liver function testing performed.
• Calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole. In addition, itraconazole can inhibit the metabolism of calcium channel blockers. Therefore, caution should be used when coadministering itraconazole and calcium channel blockers due to an increased risk of CHF. 

Pregnancy

Teratogenic effects; Pregnancy Category C

There are no adequate and well-controlled clinical trials in the pregnant women with itraconazole. However, cases of congenital abnormalities have been reported with itraconazole drug products in post-marketing reports. Therefore, it should not be administered to pregnant women, women planning pregnancy, or women of child bearing potential. Itraconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Itraconazole is excreted in human milk; therefore, the expected benefits of itraconazole therapy for the mother should be weighed against the potential risk from exposure of itraconazole to the infant.